AstraZeneca and Daiichi Sankyo’s joint product Enhertu® (fam-trastuzumab deruxtecan- nxki) has been approved for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial.

• The FDA also approved two companion diagnostics for Enhertu: Life Technologies’ Oncomine Dx Target Test (for tissue) and Guardant Health’s Guardant360 CDx (for plasma).
• Enhertu has been evaluated at two recommended doses: 4 mg/kg and 6.4 mg/kg given intravenously every 3 weeks.
• Enhertu is priced at $2,613.56 per 100mg.
• Emhertu first received FDA approval on 12/20/2019, under the provisions of accelerated approval regulations (21 CFR 314.500).